Thursday, 18 December 2014

ClinicSpeak: some reflections on my first visit to India

Why is India such an inspiring place? #MSBlog #MSResearch #ClinicSpeak

"As I reflect on my return flight from my lecture tour in India I am beginning to realise that one of the largest unmet needs in MS, globally, is access to disease-modifying therapies (DMTs). Although MS is relatively uncommon in India, the sheer size of the population means that there probably as many MSers living in India as there are in the UK, i.e. greater than 100,000. There is no NHS in India to pick-up the tab for high-cost DMTs; as a result of this less than 5% of MSers living in India are on a DMT. The only criterion for accessing DMTs in India is wealth. One neurologist told me that several of his patients are forced to buy their interferon-beta injections on a weekly basis; they simply don’t have enough money to pay for a month’s supply. His patients often miss injections as they simply unable to raise enough money to pay for the next week’s supply. Please note, these are not poor MSers, but the relatively well off. In comparison, the poor are left to face the consequences of untreated MS; the shredder is left to shred. This is why my ‘essential list of off-label DMTs’ is so important.

After speaking to many neurologists in Delhi, Bangalore and Hyderabad it became apparent that, apart from steroids, they simply don’t use off-label DMTs. For example, none I spoke to use azathioprine. This is in contrast to South Africa, where neurologists do use off-label medications in the state system. In India the MSologists practice evidence-based neurology and are of the opinion that if a drug is not licensed it should not be prescribed. I tried to explain to them that because a particular drug is not licensed for treating MS it does not mean that it is ineffective. The factors that dictate whether a drug gets licensed, or not, is largely determined by how much a drug is going to generate for the Pharma company who developed it. Drugs that are off-patent, or have a short patent life, are not going to get licensed. An executive from a large Pharma company recently told me that their break even number is $450 million per year in global sales; if a drug is projected to have sales of less than this they will disinvest and either sell it, or license it, to a smaller company to develop or they will mothball the programme. He told me that the regulatory requirements to maintain a licensed drug in Europe alone are close to €500,000 per annum. What chances have we as academics got of licensing, and maintain a license, for any of the drugs on the essential MS off-label DMT list?

The licensed DMTs have had, and have, large and sustained marketing campaigns promoting their use, which is why neurologists perceive them as being the only options for treating MS. Interestingly, with biological therapies such as the interferons and glatiramer acetate, the prevailing wisdom in India is that the biosimilars will never be as good as the innovator products. My wife who works in advertising and branding will say that is because of the power of the brand. India like any other developing country has aspirations; being able to prescribe state-of-the art licensed medication is very important to them and the patients they treat. I don’t have a problem with this practice, and actively support it; it is the majority of MSers who can’t afford the medications that I am concerned about.

Getting neurologists in resource-poor settings to adopt off-label prescribing is going to be very hard; simply blogging about it is not going to make it happen. I am going to need a much wider and smarter campaign and help from the wider MS community. Any ideas and/or help is welcome. Another option is to lobby Pharma to adopt the same strategy as they did with HIV; i.e. to have two pricing structures one for rich countries and another for developing ones. The chances of this happening, however, are low; MS is simply not politicised enough and does not have the same level of activism as the HIV community. MS is not considered a global health problem; it simply doesn’t get onto the healthcare radar in developing countries. Unfortunately, this does little to help the individual with MS. Each person with MS needs help; why should we forget about them because they live in resource poor countries and can’t afford licensed DMTs?

On a positive note I feel more energised about clinical neurology than I have been for some time. I am now almost 3 months into my sabbatical and for the first time I beginning to see a different vison of what I need to do before April 2015 when I start clinical work again. I need to get MSologists in resource poor settings to consider adopting treating-2-target of NEDA using off-label drugs. I am convinced my proposed list of drugs, if used actively as part of a strategy to treat-2-target, can make a real difference to the lives of the MSers they look after. To simply leave them to be ravaged by their disease is not an option. It was also reassuring to note that access to MRI in India is widespread and relatively cheap; much cheaper than the UK. There seemed to be a consensus that MRI monitoring of disease activity was needed, and in fact is practiced, by all the neurologists I spoke to.

The service that neurologists in India provide is truly remarkable under very challenging circumstances. On my visit to NIMHANS, a large and truly world-class neuroscience centre in Bangalore, I couldn’t quite comprehend the scale of India’s medical need. NIMHANS treats over 450,000 patients per year; they see approximately 600 new patients per day. There is no booking system; very ill patients are triaged and seen in the A&E, the others queue and are seen on a first-come first-seen basis in outpatients. Patients start queuing the night before and many wait 12-14 hours to see a neurologist. In one consulting room I met a man who left Kolkata (Calcutta) on the 5th December to travel by train and bus, to Bangalore to be seen by a neurologist on the 15th December at 11am in the morning; he had started queuing the night before. He wasn’t complaining, on the contrary, he was clearly very grateful to be seeing a neurologist. Please note this is a trip of ~1600km one-way; by the time gets home it will have taken him at least 2 weeks. This puts into perspective the waiting times of MSers at the Royal London Hospital; I get anxious when my patients have to wait longer than 30 minutes to see me.

Please note my trip to India coincided with the Indian launch of dimethyl fumarate (DMF) and was sponsored by Biogen-Idec. I spoke on NEDA, treating-2-target, end-organ damage, DMF and how I saw DMF fitting into the treatment algorithm. I suspect that only 5% or less of the MSers in India will be able to afford DMF; it is the ones who can’t afford DMF that concern me most. I would like to thank my hosts for making my trip such a remarkable one. India is an enchanting country, diverse and rich in culture; its peoples are happy and have a spiritual dimension to their lives that we in the West seem to have lost. Time takes on a different dimension in India; there is no rat race or an urgency to complete a list of tasks. I feel more relaxed and content than I have in a long, long time; I intend to make it last. I can’t wait to return to India with my family to discover more of its hidden wonders and to stay connected to its way of life and the philosophy of its peoples."CoI: multiple; please see slide 2 of presentation for specific disclosures.

I wrote about India & the lack of MS DMTs last year - You don't need to approve this link but you might find it of interest that i was also writing about the lack of treatment except for the wealthy few. I am so glad you are spreading the word about off-label uses that might be equally effective.

Would health officials benefit from providers in the west visiting to educate patients or help establish protocols? Do the non- local patients have a place to say will being treated? In order words, how can we help?

So blooming true! Part of my family is from Mumbai, via Iran (yep the MS connection there) and on the whole it is Parsis and Iranis that have MS ( they stand somewhat outside the caste system and are usually very wealthy compared to the Indian population as a whole) but the caste system is still to this day -more than anything - a blight on India's progress.

Where do you get your information about India MD2 and Anon 3.31? Many things are a 'continuous hindrance' to progress here in India; the caste system is not the worst of them. Caste doesn't matter as much as you seem to think, especially not in big cities.

I expected more professional behavior from the folks at TeamG. I had made up my mind to contribute to your crowdacure. But I am going to save my money, which I earned based on values taught to me during my Indian upbringing for some other cause!

What you do with your money is up to you but, why would you want to punish ProfG you object to the opinion of someone else. The research of ProfG will benefit from crowacure and it has nothing to do with the people that you appear to want to complain about.

I am now dreading the next visit to the neuro: now that DMF is available in India he is sure to say it's time to shift from rituximab to DMF.

Rituximab has been very effective, it is very convenient, and it is affordable - our medical insurance pays for it since it is an infusion given in hospital.

I doubt if DMF will be as effective. It will need to be taken every day and it will probably have more side effects. Worst thing is that insurance will not pay for it, because medical insurance in India does not cover outpatient treatments.

That is another reason why even relatively well-off MSers in India who do have medical insurance are mostly not on interferons. They cannot claim the cost from insurance.Since Tysabri is an infusion for which you get admitted to hospital it can be claimed, but it is too expensive. Just a few months of Tysabri will typically take most people past their annual limit.

Some more information: most insurance policies will cover a treatment only if it requires hospitalisation for 24 hours or more. So you stay in hospital that long even if the infusion can be given in a few hours.

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